Xinmin Evening News (Reporter Qiu Yingqiong) Recently, Wei Kai, Registration Regulatory Manager of Philips Ultrasound (Shanghai) Co., Ltd., received the "Registration Certificate of Medical Device" in the service hall of Shanghai Municipal Food and Drug Administration. This marked the first "localized manufacturing of imported" product in Shanghai after the National Medical Products Administration issued the "NMPA Notice on Matters Related to the Production of Imported Medical Device Products by Domestic Manufacturers in China" in September last year.
On March 15, Shanghai Municipal Review and Verification Center for Medical Devices and Cosmetics completed the technical review for the first "ultrasonic probe" under Class II medical device product ", marking the first localized manufacturing of imported medical device by domestic manufacturer in China. This product is an imported medical device of Philips (China) Investment Co., Ltd., and its domestic subsidiary Philips Ultrasound (Shanghai) Co., Ltd. applied for domestic registration.
Thanks to the "NMPA Notice on Matters Related to the Production of Imported Medical Device Products by Domestic Manufacturers in China" (No. 104 in 2020), which is referred to as "Document 104" in the industry, Philips has embarked on a new "fast lane" of review and approval. From November 13 last year to March 15 this year, the total review duration was 122 natural days, 50% shorter than the traditional average review cycle. Guo Shuting, Deputy Director of Shanghai Municipal Food and Drug Administration, explained that "Document 104" is applicable to foreign-invested enterprises established by the registrant of imported medical devices in China to produce Class II and Class III products with imported medical device registration certificate in China. When submitting the registration application materials, the applicant can provide the original registration application materials of imported medical devices, including at least four major categories, such as clinical evaluation. This also means that the pre-stage research period taken by enterprises to register a product will be greatly shortened.
"This is of great significance to the localization of imported medical devices. In the past, if we want to transfer our imported medical devices to domestic production, we may need to start local clinical trials, from the design of clinical trials to the recruitment of clinical trial subjects by hospitals and the summary of data. This process takes at least more than half a year. Now the national medical device registration policy gives us more options, " said Wei Kai
After examination and evaluation, it is confirmed that the product has achieved three major "localization" breakthroughs: First, the main production process has been localized, and the ceramic array processing process which plays a decisive role in the product performance has been completed in China; Second, the main raw material supply is localized, and the main raw material "ceramic chip" of products breaks through the technical bottleneck to avoid the high tariff burden of imported parts; Third, it is the localization of cutting-edge production and inspection equipment, digital program control equipment for ceramic processing and automatic detection equipment for impedance, isolation, polarity, air pressure, etc.
The implementation of the national new policies also needs local "supporting service". It is learned from the Shanghai Municipal Food and Drug Administration that as soon as the "Document 104" of the National Medical Products Administration was released on September 25, 2020, Shanghai Municipal Review and Verification Center for Medical Devices and Cosmetics immediately organized a special group to study the essence of policy, strictly grasp the scope of use, and timely carry out effective evaluation path exploration. On the premise of "not lowering standards", the agency has made great efforts to simplify registration data and optimize the review process.
The "bonus" of "Document 104" has attracted many enterprises. Xu Bin, Quality Director of Boston Scientific, said that the company is holding more than 300 registration certificates of imported devices. If we take the evaluation path for "localized manufacturing of imported" products, it will be very beneficial for enterprises and imported products to serve Chinese patients as soon as possible. Therefore, we are very looking forward to the new policy of National Medical Products Administration and the innovative service of Shanghai Municipal Food and Drug Administration.
Source: Xinmin Evening News
On March 15, Shanghai Municipal Review and Verification Center for Medical Devices and Cosmetics completed the technical review for the first "ultrasonic probe" under Class II medical device product ", marking the first localized manufacturing of imported medical device by domestic manufacturer in China. This product is an imported medical device of Philips (China) Investment Co., Ltd., and its domestic subsidiary Philips Ultrasound (Shanghai) Co., Ltd. applied for domestic registration.
Thanks to the "NMPA Notice on Matters Related to the Production of Imported Medical Device Products by Domestic Manufacturers in China" (No. 104 in 2020), which is referred to as "Document 104" in the industry, Philips has embarked on a new "fast lane" of review and approval. From November 13 last year to March 15 this year, the total review duration was 122 natural days, 50% shorter than the traditional average review cycle. Guo Shuting, Deputy Director of Shanghai Municipal Food and Drug Administration, explained that "Document 104" is applicable to foreign-invested enterprises established by the registrant of imported medical devices in China to produce Class II and Class III products with imported medical device registration certificate in China. When submitting the registration application materials, the applicant can provide the original registration application materials of imported medical devices, including at least four major categories, such as clinical evaluation. This also means that the pre-stage research period taken by enterprises to register a product will be greatly shortened.
"This is of great significance to the localization of imported medical devices. In the past, if we want to transfer our imported medical devices to domestic production, we may need to start local clinical trials, from the design of clinical trials to the recruitment of clinical trial subjects by hospitals and the summary of data. This process takes at least more than half a year. Now the national medical device registration policy gives us more options, " said Wei Kai
After examination and evaluation, it is confirmed that the product has achieved three major "localization" breakthroughs: First, the main production process has been localized, and the ceramic array processing process which plays a decisive role in the product performance has been completed in China; Second, the main raw material supply is localized, and the main raw material "ceramic chip" of products breaks through the technical bottleneck to avoid the high tariff burden of imported parts; Third, it is the localization of cutting-edge production and inspection equipment, digital program control equipment for ceramic processing and automatic detection equipment for impedance, isolation, polarity, air pressure, etc.
The implementation of the national new policies also needs local "supporting service". It is learned from the Shanghai Municipal Food and Drug Administration that as soon as the "Document 104" of the National Medical Products Administration was released on September 25, 2020, Shanghai Municipal Review and Verification Center for Medical Devices and Cosmetics immediately organized a special group to study the essence of policy, strictly grasp the scope of use, and timely carry out effective evaluation path exploration. On the premise of "not lowering standards", the agency has made great efforts to simplify registration data and optimize the review process.
The "bonus" of "Document 104" has attracted many enterprises. Xu Bin, Quality Director of Boston Scientific, said that the company is holding more than 300 registration certificates of imported devices. If we take the evaluation path for "localized manufacturing of imported" products, it will be very beneficial for enterprises and imported products to serve Chinese patients as soon as possible. Therefore, we are very looking forward to the new policy of National Medical Products Administration and the innovative service of Shanghai Municipal Food and Drug Administration.
Source: Xinmin Evening News